Status:
UNKNOWN
A Study to Compare the Pharmacokinetics and Safety of CT-P47 and RoActemra in Healthy Subjects
Lead Sponsor:
Celltrion
Conditions:
Healthy Subjects
Eligibility:
All Genders
19-55 years
Phase:
PHASE1
Brief Summary
A study to Compare the Pharmacokinetics and Safety of CT-P47 and RoActemra in Healthy Subjects
Detailed Description
Subjects will be randomized in a 1:1 ratio to receive a single dose (162 mg) of either CT-P47 or EU-approved RoActemra.
Eligibility Criteria
Inclusion
- Healthy subjects
- Body weight of ≥60 and ≤100 kg for male and ≥50 and ≤100 kg for female and a BMI between 18.5 and 28.0 kg/m2 (both inclusive) when rounded to the nearest tenth
Exclusion
- A medical history and/or condition that is considered significant
- Clinically significant allergic reactions, hypersensitivity
- History or current infection of hepatitis B virus, hepatitis C virus, human immunodeficiency virus, or syphilis
- Active or latent Tuberculosis
- History of malignancy
- Previous exposure to tocilizumab or any drug that targets IL-6
Key Trial Info
Start Date :
December 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2023
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT05188378
Start Date
December 22 2021
End Date
January 31 2023
Last Update
January 12 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Seoul National University Hospital
Seoul, South Korea, 03080